ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06146842
Phase
PHASE4
Status
Recruiting
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Conditions

  • Labor Pain

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Bupivacaine Hydrochloride — DRUG
    Each subject will receive allocated dose of bupivacaine

Study Details

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

Key Dates

Start date
Dec 1, 2023
Status verified
Jan 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DPE Group
    Subjects will receive an epidural catheter via a dural puncture epidural technique.
  • Active Comparator: EPL Group
    Subjects will receive an epidural catheter via a traditional epidural technique.

Primary Outcome Measure

NRS <3 at 30 min [ Time Frame: 30 minutes after time 0. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ayumi Maeda, MD PhD
[email protected]
1-617-732-8216

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By research site
Brigham and Women's Hospital· Boston, MA

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